low carbohydrate diet, glycaemic control and quality of life in australian adults with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in australian adults with t1dm. the first phase of the study will develop and validate a diabetes specific quality of life questionnaire for adults with t1dm. the second phase will undertake a low carbohydrate diet intervention and examine its association with quality of life and glycaemic control, pre and post the dietary intervention. the novel outcomes will include a new validated australian t1dm specific quality of life questionnaire and an investigation as to whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in australian adults with t1dm.

phase 1: aim: to develop a reliable and valid diabetes specific quality of life questionnaire for use in australian adults living with type 1 diabetes mellitus (t1dm). objectives: 1. to develop a new australian diabetes specific quality of life online questionnaire integrating participant feedback using a one to one interview method; 2. pilot the study developed online questionnaire with adults that have type 1 diabetes mellitus and 3. conduct factorial validation of the study developed online questionnaire using advanced statistical modelling techniques. phase 2: aim: the aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in adults living with t1dm. objectives: 1. to examine the association between quality of life and glycaemic control in adults with t1dm; 2. implement a low carbohydrate diet in a cohort of adults living with t1dm; 3. examine the association between a low carbohydrate diet and glycaemic control in adults with t1dm: pre and post intervention; 4. examine the association between quality of life and a low carbohydrate in adults with t1dm: pre and post intervention and 5. investigate whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in adults with t1dm.

Eligibility criteria:
inclusion criteria: * male, female or unspecified gender; * 18 years of age or over; * type 1 diabetes for ≥1 year from diagnosis date and * individuals who administer insulin using multiple daily injections. exclusion criteria: * patients with type 2 diabetes mellitus; * patients with gestational diabetes mellitus; * presence of a known food allergy or intolerance that may affect the participants' health or adherence during the intervention; * history of an eating disorder; * bmi \<25.0kg/m2 to 29.9kg/m2; * age \<18 years; * an active medical problem that may hinder the persons' ability to take part or potentially affect study outcomes e.g. a recent myocardial infarction, stroke or peripheral revascularisation (within 3 months), active treatment of diabetic retinopathy, recent serious infection (requiring in-hospital treatment or prolonged antibiotic therapy), active mental health complaint or other active medical problems determined by medical staff; * pregnancy or expectation of conceiving. participants will be withdrawn at any stage from the study if pregnancy occurs; * the use of medications that may affect body weight/body composition (including but not limited to phentermine and corticosteroids); * those for whom the written materials may be unsuitable such as vision impaired or illiterate individuals; * those unable to understand english; * those who failed to provide informed consent and * those who administer insulin using a continuous subcutaneous insulin infusion.

Keywords: quality of life glycaemic control low carbohydrate diet